This website covers knowledge management, personal effectiveness, theory of constraints, amongst other topics. Opinions expressed here are strictly those of the owner, Jack Vinson, and those of the commenters.

Electronic clinical patient data

Bio-IT World in July 2003 has an article on moving to PDA-based recording, rather than the traditional patient diaries. Patient, Record Thyself - Archive

A recent study is making the inadequacies of paper-based diaries much more difficult to brush under the carpet. In a paper on chronic pain, published by psychiatrists at Stony Brook University in April ("Patient compliance with paper and electronic diaries," Control Clin Trials 24,182-99), the number of patients who recorded their experiences as instructed was only 11 percent among those using paper diaries, compared with 90 percent of patients with a personal digital assistant.

Note: It appears this study was sponsored by the vendor of the electronic diary.

This is an old problem. How do you get field data accurately and timely without intruding into the life of the patient too much. Paper diaries are too easy to "fake" or simply fill out at the end of the week, well after the experience in question. While the electronic diaries are easier to use, people can still record their memory of the event rather than recording in real time.

This type of solution is on target, though. It also solves a number of other nagging problems with clinical data collection. The standard in the industry is to have two different people key data from paper logs. (To help ensure data accuracy.) This is slow and provides absolutely no feedback to the patient. Electronic connections immediately drop data into a database -- or can send it through a scrubbing process -- which can give patients a quick report of how they are doing. Electronic data transfer also provides faster feedback to the doctors, nurses and clinical trial administrators on how patients are doing and how they are keeping up with the plan.

On the other side, there is the big 21 CFR Part 11 and HIPAA questions of data integrity, accuracy and privacy. The primary vendor argues that this system is has more integrity than current paper systems, and their product has been used in a successful FDA filing.

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